Clinical trial material facility

A gowned and masked lab worker wearing gloves works at a computer station next to a large lab instrument.

The National Research Council of Canada's clinical trial material facility is uniquely positioned to help Canadian innovators advance novel biologics through clinical trials in Canada.

Located in Montréal, Quebec, the clinical trial material facility bridges the gap between biomanufacturing research and commercial production.

This 1,700-square-metre facility is designed for developing biopharmaceuticals such as vaccines and therapeutics in collaboration with industry, hospitals, health networks, academia and other government departments.

The clinical trial material facility is operated by the Human Health Therapeutics Research Centre, which has established biomanufacturing expertise and one of the largest research and development teams in Canada dedicated to biologics development.

Clinial trial material facility video: Transcript

[On screen: Clinical trial material facility]

Welcome to the National Research Council of Canada's clinical trial material facility.

We're uniquely positioned to help advance novel biologics through clinical trials in Canada and bridge the gap between biomanufacturing research and commercial production.

Our 1,700-square-metre facility is compliant with good manufacturing practices recognized in Canada, the United States and Europe.

It's operated by our knowledgeable team, with expertise in developing and scaling up robust biomanufacturing processes.

The clinical trial material facility is designed for biopharmaceuticals such as vaccines and therapeutics, and is ideally suited for producing clinical trial material, optimizing and verifying processes, technology transfer and early process validation.

In our sub-culture suite, we can optimize conditions for cell growth in successively larger vessels, up to 5 litres.

Optimal cell growth continues up to 500 litres in the upstream processing suite, where cell transfection or induction takes place.

Once the cell culture has produced the desired yield, the product of interest is transferred to our first downstream processing suite, where it's separated and purified, as needed, to generate the drug substance.

Depending on your needs, we can carry out additional concentration, pre-formulation and filtration in our second downstream processing suite before the bulk drug substance is packaged for shipping.

The NRC's clinical trial material facility. With state-of-the-art infrastructure and established biomanufacturing expertise, we're accelerating biologics development in Canada.

Let's make your innovation, our next project.

[On screen: official signature, National Research Council Canada / Conseil national de recherches Canada]

[On screen: Government of Canada Wordmark]

About the facility

With its state-of-the-art public infrastructure and our established biomanufacturing expertise, the clinical trial material facility is ideally suited for production process optimization, technology transfer and small-scale biologics production.

Key features

  • Compliant with good manufacturing practices (GMP) recognized by Canadian, American and European regulatory authorities
  • Single-use production
  • Containment levels 1 and 2
  • Unidirectional design
  • 50-litre and 500-litre bioreactors
  • Virus inactivation and nanofiltration
  • Pre- and post-virus purification train
  • Tangential flow filtration (ultrafiltration)
  • Cell amplification, production and clarification using depth filtration
  • Chromatography skids for purification and polishing steps
  • Bulk fill
  • Process control capabilities

Types of production

  • Fusion proteins
  • Monoclonal antibodies
  • Viral vectors
  • Protein sub-units
  • Virus-like particles
  • Gene therapies

Quality management system

The clinical trial material facility's quality management system provides overall guidance to ensure consistent and sustainable production of safe and effective products in compliance with GMP and applicable processes, policies, standards and regulations.

The quality management system integrates effective knowledge building, risk management and GMP requirements into all stages of our processes. It also provides a framework for knowledge transfer from clients to our teams in preparation for manufacturing clinical trial material.

Make your innovation our next project

The clinical trial material facility offers safe and reliable small-scale production capacity. Our processes are GMP-compliant and meet the standards of Canadian, American and European regulatory authorities.

Our experts are experienced, prepared and ready to help advance your biologic innovation through the final stages of R&D and with the production of material for phase I and phase II clinical trials.

We can help increase the success and impact of your novel biologics project. Contact us to learn more.

Potential client use

  • Clinical trial material production (proteins, antibodies, vaccines, gene therapies)
  • Technology transfer hub
  • Optimization of GMP manufacturing processes
  • GMP cell banks

Location

6100 Royalmount Avenue
Montréal, Quebec H4P 2R2

Related links

Targeted industries

Health and Biosciences, Biopharmaceuticals, Pharmaceuticals, Pharmaceutical Manufacturing, Personalized / Precision Medicine, Bioproducts